NCT01230125

Brief Summary

The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

October 25, 2010

Results QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Cataract

Keywords

InflammationPainOcular surgery

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.

    Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.

    8 days

  • Percentage of Participants With Grade 0 Pain

    Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, were higher scores indicated worse pain.

    8 days

Secondary Outcomes (1)

  • Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.

    8 days

Study Arms (2)

Mapracorat

EXPERIMENTAL

Ophthalmic suspension 3%

Drug: Mapracorat

Vehicle

PLACEBO COMPARATOR

Vehicle of mapracorat ophthalmic suspension

Drug: Vehicle

Interventions

MapracoratDRUG

Instill study medication into study eye per dosing instructions for 14 days

Also known as: BOL-303242-X
Mapracorat
VehicleDRUG

Instill study medication into the study eye per dosing instructions for 14 days

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are candidates for routine, uncomplicated cataract surgery
  • Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
  • Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

You may not qualify if:

  • Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
  • Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
  • Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
  • Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

CataractInflammationPain

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Study Officials

  • Rabia Ozden, MD

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 28, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

September 3, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-08

Locations

US(1)